Addition of boceprevir significantly increased treatment success
in more patients and in a significantly shorter time period
compared to standard treatment

MONTREAL, March 30 /CNW/ -Two Phase III studies (HCV RESPOND-2
and HCV SPRINT-2) are published in the March 31 edition of the New
England Journal of Medicine (NEJM) demonstrating that addition of
the investigational oral medication boceprevir to standard
treatment significantly improved sustained virologic response (SVR)
- the goal of treatment - in a significantly greater number of
adult patients who failed previous treatment (treatment-failure)
and in those who were new to treatment (treatment-naïve) for
chronic hepatitis C virus (HCV) genotype 1, compared to standard
therapy alone. Also, both studies investigated a new treatment
strategy resulting in many patients being able to shorten the
duration of therapy from the standard 48 weeks.1

"These results signal a truly important change in the treatment
of hepatitis C genotype 1 infection, one of the most prevalent
genotypes in Canada," said Dr. Marc Bilodeau, a Canadian
investigator in the SPRINT-2 study and Associate Professor of
Medicine at Université de Montréal<http://en.wikipedia.org/wiki/Universit%C3%A9_de_Montr%C3%A9al>.
"The addition of boceprevir not only substantially increased the
success rates, but also by using response-guided therapy - which
indicates how individuals are responding to treatment - many
patients taking the drugs for the first time saw their treatment
times cut almost in half."

"Being able to shorten the length of treatment is extremely
important given that one of the most challenging aspects of
treating HCV is managing the debilitating side effects. Because the
side effects are so hard to take, unfortunately some patients stop
their course of therapy," said Dr. Mark Levstik, an investigator in
the SPRINT-2 NEJM-published study and Assistant Professor,
Department of Medicine, Division of Gastroenterology, University of
Western Ontario.

Boceprevir, an investigational agent not currently available in
Canada, belongs to a novel class of direct-acting antiviral agents
- called HCV protease inhibitors - that reduce the amount of virus
in the blood through inhibition of the function of a viral protein
called 'protease' that HCV needs to replicate.2

An estimated 250,000 individuals in Canada are infected with HCV
and there are 3,200 to 5,000 newly infected individuals each year.3
HCV damages the liver and may lead to serious complications,
including death, when left untreated.4 It is the leading cause of
liver transplants in Canada.5

"The use of a protease inhibitor to treat hepatitis C infection
is an important advance in the management of the disease," said Dr.
Alnoor Ramji, an investigator in both the SPRINT-2 and the
RESPOND-2 published studies and a Clinical Assistant Professor at
the University of British Columbia. "As a Canadian investigator, I
am encouraged that the studies have been published in this
prestigious medical journal. It reinforces the importance of our
results."

Treatments Improve, Stigma Persists

Karen Stacey lived with the virus for many years before
experiencing any symptoms. Her diagnosis came slowly, and only
after many tests and visits to multiple physicians.

"I remember constantly feeling dizzy and nauseous, and having a
hard time with my memory," said Ms. Stacey. "When I was finally
diagnosed with hepatitis C, I had this sinking feeling that people
felt I deserved to get this disease. In the minds of many people,
only drug addicts or alcoholics get this virus."

Past or current drug use accounts for more than 56 per cent of
all hepatitis C infection in Canada.6 In addition, the virus may be
contracted via use of unscreened blood or blood products in medical
procedures, body piercing, mother-child transmission and accidental
needle-sticking in medical settings. In Karen's case, she
contracted the virus following a blood transfusion, which she
required during a failed pregnancy in the 1970s.

"To help eliminate the terrible stigma I suffered following my
diagnosis, I'm dedicated to educating Canadians about the disease,"
said Ms. Stacey. "The most frightening thing about the stigma is
that it creates an enormous barrier for people infected with
hepatitis C to get diagnosed and receive treatment that could cure
their disease."

About HCV: A Silent Disease

Approximately one-in-three of those infected with HCV are not
aware of their infection and it often goes undetected for many
years until symptoms appear.7 Symptoms can include fever, fatigue,
reduced appetite, stomach pain, dark urine, jaundice (yellowing of
skin or eyes), nausea and vomiting, aching muscles and joints, and
poor concentration.8 If left untreated, HCV may lead, in some
patients, to liver fibrosis, cirrhosis, liver cancer and liver
failure.9

About the Studies

The two studies (HCV RESPOND-2 and HCV SPRINT-2) each evaluated
two new treatment strategies with boceprevir administered in
combination with peginterferon alfa-2b and ribavirin (PR) to assess
the ability of boceprevir to improve SVR rates - the goal of
treatment - and potentially shorten overall treatment duration
compared to the use of PR alone for 48 weeks, which is the current
standard duration of therapy.

The HCV RESPOND-2 study examined the use of boceprevir in adult
patients who previously failed to eradicate the virus with current
standard therapy, including patients who had either relapsed after
initially clearing the virus or were non-responders to prior
treatment with PR. The HCV SPRINT-2 study examined the use of
boceprevir in adult patients who were treatment-naïve (no
prior treatment).

A total of 1,500 patients participated in the two studies, with
nearly 10 per cent of patients (146) recruited at 15 Canadian
investigation sites. In each study, patients were randomized to one
of three treatment arms:

* Response-guided therapy (RGT), in which total treatment
duration was based on certain early response criteria.
Treatment-failure patients with undetectable virus (HCV-RNA) at
week eight were eligible to stop all treatment at 36 weeks.
Treatment-naïve patients who had undetectable virus (HCV-RNA)
during weeks eight through 24 were eligible to stop all treatment
at 28 weeks. * 48 weeks of treatment, in which patients received a
four-week lead-in with PR followed by the addition of boceprevir
for 44 weeks. * Control, in which patients received PR for 48
weeks.

In the HCV RESPOND-2 study (treatment-failure patients), the
addition of boceprevir in the RGT arm resulted in 59 per cent of
patients eliminating the virus and 66 per cent in the 48-week
treatment arm, compared to 21 per cent in the control group
(p<0.0001).

In the HCV SPRINT-2 study (treatment-naïve patients), the
addition of boceprevir in the RGT arm resulted in 63 per cent of
patients eliminating the virus and 66 per cent for the 48 week
treatment arm, compared to 38 per cent in the control group
(p<0.0001).

Study authors reported that nearly half of all patients in the
RGT arms of both studies met the early response criteria, meaning
that they received a shorter total duration of therapy. In the HCV
RESPOND-2 study, 46 per cent of patients met the early response
criteria, and were able to stop all treatment at 36 weeks (12 weeks
shorter than current standard therapy). In the HCV SPRINT-2 study,
44 per cent of patients met the early response criteria and were
able to stop all treatment at 28 weeks (20 weeks shorter than
current standard therapy).

In the HCV RESPOND-2 study, the most commonly reported side
effects were fatigue, headache, nausea, chills and influenza-like
illness. Serious adverse events were reported in 10 per cent of
patients in the RGT arm of the study, 14 per cent of patients in
the 48-week treatment arm and in five per cent of patients in the
control group. Discontinuation of treatment due to adverse events
over the total course of the study was eight per cent in the RGT
arm, 12 per cent for the 48-week treatment arm and three per cent
for control.

Tolerability profile in treatment-failure patients

The five most common treatment-related adverse events in the HCV
RESPOND-2 study reported for patients receiving boceprevir in RGT,
boceprevir in a 48-week treatment regimen and control,
respectively, were: fatigue, headache, nausea, anemia and chills.
Serious adverse events were reported in 10, 14 and five per cent of
patients in the study arms, respectively. There was one death in
the study, a suicide in the group receiving boceprevir in RGT,
which occurred 18 weeks after the end of the study treatment and
was considered to be unrelated to the study treatment.

Treatment discontinuations due to adverse events over the total
course of all treatment were eight per cent and 12 per cent for
patients receiving boceprevir in RGT and boceprevir in a 48-week
treatment regimen, respectively, compared to two per cent for
control. Treatment discontinuations due to anemia were 0 per cent
and three per cent for the treatment groups receiving boceprevir,
respectively, compared to 0 per cent for control.

Tolerability profile in treatment-naïve patients

The five most common treatment-related adverse events in the HCV
SPRINT-2 study reported for patients receiving boceprevir in RGT,
boceprevir in a 48-week treatment regimen and control,
respectively, were: fatigue, headache, nausea, anemia and dysgeusia
(bad taste). Serious adverse events were reported in 11, 12 and
nine per cent of patients in the study arms, respectively. There
were six deaths during the study: four patients in the control
group died, as did two patients in the boceprevir groups. Two
suicides (one patient in the control group and one patient
receiving boceprevir in RGT) were judged to have possibly been
related to peginterferon. No other deaths were considered to be
drug-related.

Treatment discontinuations due to adverse events over the total
course of all treatment were 12 per cent and 16 per cent for
patients receiving boceprevir in RGT and boceprevir in a 48-week
treatment regimen, respectively, compared to 16 per cent for
control. Treatment discontinuations due to anemia were two per cent
for each of the treatment groups receiving boceprevir compared to
one per cent for control.

The HCV RESPOND-2 and HCV SPRINT-2 studies each employed
futility or "stopping" rules, whereby patients in any treatment arm
who had detectable virus at week 12 in the HCV RESPOND-2 study or
at week 24 in the HCV SPRINT-2 study were considered treatment
failures and discontinued all treatment. The stopping rules allowed
study patients who did not respond to treatment to have therapy
stopped early, thereby avoiding unnecessary treatment.

Boceprevir is an investigational medication and not currently
available in Canada.

Merck's global commitment to advancing hepatitis therapy

Merck is committed to building on its strong legacy in the field
of viral hepatitis by continuing to discover, develop and deliver
vaccines and medicines to help prevent and treat viral hepatitis.
Extensive research efforts are underway to develop differentiated
oral therapies that bring innovation to viral hepatitis care.

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therapies, and consumer care and animal health products, we work
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innovative health solutions. We also demonstrate our commitment to
increasing access to healthcare through far-reaching policies,
programs and partnerships. For more information, visit www.merck.ca<http://www.merck.ca>.

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